AAV CMC Consultant (Independent Contractor)

The Resume Database; United States; Remote; USD 248,000 - 386,000; Part time

Job summary

The Resume Database is seeking an AAV CMC Consultant (Independent Contractor) to work remotely from the United States on a six-month engagement. You will bring advanced CMC expertise to an adeno-associated virus gene therapy program, assess manufacturing readiness, and drive regulatory documentation in collaboration with an external CDMO.

This role emphasizes scientific rigor, strategic regulatory planning, and hands-on project leadership, with accountability for timelines and deliverables.

Qualifications

• Specialized CMC expertise for gene therapy programs.
• Experience with regulatory strategy and IND submissions.
• Experience coordinating with external CDMOs and vendors.

Responsibilities

• Assess manufacturing readiness for AAV CMC processes.
• Define priorities and drive execution to timelines.
• Lead technical meetings and translate challenges into actions.
• Oversee regulatory documentation and submissions.

Skills

CMC expertise

AAV biology

Regulatory strategy

Vendor management

Education

PhD in relevant field

Job description

AAV CMC Consultant (Independent Contractor)

October 16, 2026

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an AAV CMC Consultant (Independent Contractor) based in the United States .

This is an opportunity to help advance an innovative adeno-associated virus (AAV) gene therapy program toward its first-in-human clinical trial. You will bring specialized Chemistry, Manufacturing, and Controls (CMC) expertise to a high-impact therapeutic development project targeting prevalent, age-related diseases. Working closely with an external Contract Development and Manufacturing Organization (CDMO), you will assess manufacturing readiness, define priorities, and drive execution against an ambitious timeline. Your expertise will shape process development, analytical strategy, manufacturing quality, and regulatory documentation. You will lead technical working meetings, translate complex challenges into actionable recommendations, and hold external partners accountable for agreed deliverables. The engagement combines scientific rigor, regulatory strategy, and hands‑on project leadership in a flexible, remote consulting environment. This approximately six-month contract offers the opportunity to influence a pioneering gene therapy program as it progresses toward IND submission and first-in-human studies.